Goal Project goal was to research and determine regulatory strategy to market a mobile medical app as a diagnostic aid to determine level of cognitive functioning. Background A European startup company developed a mobile device app known as Standardized Mental Capacity Assessment. This app is intended as a diagnostic aid to determine level of cognitive […]
Goal To determine the gaps in documentation between the existing CE Technical File (and other historical design documents) and the requirements of a design history file (DHF) Background A global premier health care company provides products and services for renal dialysis has designed and manufacturers a therapy system for continuous renal replacement therapy (CRRT), intended
Mapping the Path to FDA Clearance: MAE Group’s DHF Compliance Efforts in Renal Dialysis Read More »
Regulatory Affairs, Success Stories
Goal The project goal was to secure CE Marking for a Molecular Breast, Imaging medical device according to the European Medical Device Directive. Background A US medical device company developed a molecular breast imaging therapy system used as an adjunct to standard mammography that measure and image the distribution of radionuclides to aid in the
Goal The project goal was to lead the global recall of Post-Operative Knee Brace medical device Background A US-based orthopedic rehabilitation products company designs and manufactures, a knee brace intended to control the range of motion at the knee joint following surgeries and other structural repairs. Due to a failure in the mechanical hinge, the
Recall Resolution: MAE Group’s Strategic Approach to Knee Brace Safety Read More »
Regulatory Affairs, Success Stories